King Brett, Ohyama Manabu, Senna Maryanne, Shapiro Jerry, Dutronc Yves, Durand Frederick, Liu Chunyuan, Yu Guanglei, Kolodsick Jill, Chiasserini Chiara, Somani Najwa, Piraccini Bianca Maria
Department of Dermatology, Yale School of Medicine, New Haven, Connecticut.
Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
J Am Acad Dermatol. 2025 Feb;92(2):299-306. doi: 10.1016/j.jaad.2024.09.072. Epub 2024 Oct 22.
Baricitinib, an oral selective Janus kinase inhibitor, is approved to treat adults with severe alopecia areata (AA).
To report the week 152 efficacy results from the phase 3 trial BRAVE-AA2 down-titration substudy.
BRAVE-AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). Baricitinib 4-mg-treated patients achieving a clinical response (SALT score ≤20) at week 52 were rerandomized 1:1 to stay on 4-mg or down-titrate to 2-mg. The last observation carried forward was used to impute missing or censored data.
At week 52, 86/234 (36.8%) baricitinib 4-mg-treated patients were eligible for down-titration; 44 remained on 4-mg while 42 down-titrated to 2-mg. At week 152, 39/44 (88.6%) 4-mg-treated patients had maintained clinical response, compared to 24/41 (58.5%) down-titrated patients. Among down-titrated patients, loss of treatment benefit was less frequent in those with sustained response and SALT score ≤5 at week 52.
Method and timing of down-titration were prespecified in the protocol based on week 52 responder status and not on other clinical factors.
More than half of down-titrated patients maintained response. Sustained treatment response and/or near-total regrowth may be associated with a greater likelihood of response maintenance after down-titration.
巴瑞替尼是一种口服选择性 Janus 激酶抑制剂，已被批准用于治疗重度斑秃（AA）成人患者。
报告 3 期 BRAVE-AA2 试验减量亚研究的第 152 周疗效结果。
BRAVE-AA2 研究纳入了 546 例重度 AA 成人患者（脱发严重程度工具[SALT]评分≥50）。在第 52 周达到临床缓解（SALT 评分≤20）的接受 4mg 巴瑞替尼治疗的患者按 1:1 比例重新随机分组，继续使用 4mg 或减量至 2mg。采用末次观察值结转法来估算缺失或删失数据。
在第 52 周时，86/234（36.8%）接受 4mg 巴瑞替尼治疗的患者符合减量条件；44 例继续使用 4mg，42 例减量至 2mg。在第 152 周时，接受 4mg 治疗的患者中有 39/44（88.6%）维持了临床缓解，而减量患者中这一比例为 24/41（58.5%）。在减量患者中，第 52 周持续缓解且 SALT 评分≤5 的患者治疗获益丧失的情况较少见。
减量的方法和时机在方案中是根据第 52 周的缓解者状态预先确定的，而非基于其他临床因素。
超过半数的减量患者维持了缓解。持续的治疗反应和/或接近完全再生可能与减量后维持反应的可能性更大有关。
